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International Journal of Urology (2014) 21, 1291–1294
Letters to the Editor Linguistic validation of the English version of the Core Lower Urinary Tract Symptom Score The Core Lower Urinary Tract Symptom Score is a selfadministered symptom questionnaire to assess 10 relevant lower urinary tract symptoms thoroughly.1 The Core Lower Urinary Tract Symptom Score was originally developed concurrently in both Japanese and English by bilingual Japanese urologists. Although the English translation had been reviewed by native English-speaking translators, it had not been linguistically validated. We therefore examined the appropriateness of the English version. Appropriate translation requires that the translated version is conceptually equivalent to the original questionnaire, and is also linguistically relevant and acceptable in the target country.2,3 The appropriateness of the translation was examined through the following two steps: translation quality assessment and cognitive debriefing. In translation quality assessment, the soundness of the expressions from a clinical perspective was discussed with six native English-speaking urologists. They all approved the scientific compatibility of the questionnaire with the definitions of the corresponding symptoms by the International Continence Society.4 Regarding understandability of the questionnaire by lay people, minor issues were raised. For the cognitive debriefing, Clinical Study Support Inc. (Aichi, Japan), a research agency, independently recruited and interviewed participants after ethical approval was granted by The University of Tokyo. Five native English-speaking Americans residing in Japan were debriefed to ensure that they were able to read and understand the translation properly (two men and three women, mean age 65.2 years, mean questionnaire
Table 1
completion time 1.8 min).2 All of the participants responded that the questionnaire was, overall, easy to understand and answer. However, several issues were raised and discussed, as follows. First, although all the participants understood the meaning of Q3, four participants commented that “postpone”1 is not a common word and suggested an alternative word, such as “control”, “hold”, “prevent” or “stop”. Consequently, “postpone” was replaced with “control” for better understanding. Similarly, although all the participants understood the meaning of Q5, one participant commented that “strain” is not commonly used. Thus, “strain” was changed to “exert yourself ”. Second, two participants commented that in Q9, the location of “bladder” was not easy to imagine; therefore, we added an explanation in parentheses. Finally, one participant pointed out that the question items should be in past tense to emphasize that the questionnaire is asking about the past week. In response, all of the questions were revised to the past tense. Additionally, to make the questions sound more natural, the following wordings were revised: no to never (answer choice); and incomplete emptying of the bladder to emptying the bladder incompletely (Q8). After these revisions, the translation was back-translated into Japanese. The original developers confirmed conceptual equivalence between the translation and the Japanese CLSS (Table 1). In conclusion, the appropriateness of the translated English version of the Core Lower Urinary Tract Symptom Score was confirmed after assessing translation quality and carrying out cognitive debriefing.
Core Lower Urinary Tract Symptom Score Questionnaire
Please circle the number that applies best to your urinary condition during the last week. Q1. How many times did you typically urinate from waking in the morning until sleeping at night?
0 1 2 3 −7 8–9 10–14 15– Q2. How many times did you typically urinate from sleeping at night until waking in the morning? 0 1 2 3 0 1 2–3 4– How often did you have the following symptoms? Never Rarely Sometimes Often Q3. A sudden strong desire to urinate, which is difficult to control 0 1 2 3 Q4. Leaking of urine because you cannot hold it 0 1 2 3 Q5. Leaking of urine, when you cough, sneeze, or exert yourself 0 1 2 3 Q6. Slow urinary stream 0 1 2 3 Q7. Need to strain when urinating 0 1 2 3 Q8. Feeling of emptying the bladder incompletely after urination 0 1 2 3 Q9. Pain in the bladder (lower belly) 0 1 2 3 Q10. Pain in the urethra 0 1 2 3 Q11. Among the symptoms above (questions 1 to 10), please choose up to 3 symptoms that you consider to have had a significant impact on your daily life. 1 2 3 4 5 6 7 8 9 10 Not applicable Q12. Among the symptoms you chose in Q11, please choose one symptom that you consider to have had the most significant impact on your daily life. 1 2 3 4 5 6 7 8 9 10 Not applicable Q13. If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted Pleased Mostly satisfied Mixed, about equally satisfied and dissatisfied Mostly dissatisfied Unhappy Terrible 0 1 2 3 4 5 6
© 2014 The Japanese Urological Association
1291
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LETTERS TO THE EDITOR
Acknowledgment
References
We thank Dr Motoki Saito, Department of Pharmacology, School of Medicine, Kochi University, Nankoku, Japan, for introducing native English-speaking urologists to us.
1 Homma Y, Yoshida M, Yamanishi T, Gotoh M. Core Lower Urinary Tract Symptom score (CLSS) questionnaire: a reliable tool in the overall assessment of lower urinary tract symptoms. Int. J. Urol. 2008; 15: 816–20. 2 Wild D, Grove A, Martin M et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes measures: report of the ISPOR task force for translation and cultural adaptation. Value Health 2005; 8: 94–104. [Cited 20 May 2011.] Available from URL: http://www.ispor.org/workpaper/research_practices/PROTranslation _Adaptation.pdf. 3 Dewolf L, Koller M, Velikiva G et al.; on behalf of the EORTC Quality of Life Group. EORTC Quality of Life Group Translation Procedure, 3rd edn. EORTC Quality of Life Group Publication, Brussels, 2009. 4 Abrams P, Cardozo L, Fall M et al. The standardization of terminology of lower urinary tract function: report from the Standardisation Sub-Committee of the International Continence Society. Neurourol. Urodyn. 2002; 21: 167–78.
Yukio Homma M.D., Ph.D. and Tetsuya Fujimura M.D., Ph.D. Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan [email protected] DOI: 10.1111/iju.12584
Conflict of interest YH received research funding and speech honorarium from Astellas Pharma, Kyorin Pharmaceutical, Ono Pharmaceutical, Taiho Pharmaceutical and Pfizer Japan.
Female urethra is actively opened out by an external striated muscle mechanism during micturition, exponentially reducing intraurethral resistance to flow against the uterosacral ligaments to actively open the posterior urethral wall before detrusor contraction, as shown by Watanabe et al.1 X-ray evidence of this external opening mechanism was presented in the second exposition of the theory in 1993,3 and further X-ray and electromyography evidence in 1997.4,5 This external striated muscle mechanism causes the urethra to funnel, exponentially lowering the resistance to flow immediately before the expulsive action of the detrusor, resistance to flow being exponentially determined inversely to the fifth power of the radius.6 To find a clinical imperative for such a mechanism, one need look no further than paraplegics: cord
I am writing to support the findings of Watanabe et al., who showed that the urethra actively opens from the very beginning of micturition.1 This is important work, as the overwhelming concept at the moment is that the pelvic muscles relax before and during micturition. I present our own work in this field. In 1990, the integral theory described three vectors acting around the pubourethral ligament: forward, backwards and downwards to activate urethral closure, shown in Figure 1. The theory predicted that immediately before the commencement of voiding, the forward closure vector (pubococcygeus muscle) relaxed.2 This allowed the posterior vectors (levator plate and the conjoint longitudinal muscle of the anus) to contract
S
(a) B
PUL
U
(b)
B
USL V
Bv
S USL
CX CX
R LP
PUL
R V
LP
Fig. 1 Normal patient. X-rays (a) at rest and (b) during micturition, the same patient in a sitting position. At rest, slow twitch contractions angulate the bladder (B), urethra (U), vagina (V) and rectum (R) around the insertion of the pubourethral ligament (PUL) at the midurethra; 10 mL of radiopaque material has been injected into the levator plate (LP), vagina and rectum. Vertical and horizontal broken lines indicate bony co-ordinates. (b) During micturition, the urethra has moved backwards and actively opened out, suggesting relaxation of the forward vector and an active mechanism, which stretches the posterior urethral wall backwards. The vagina and rectum appear to have been stretched backwards by a backward vector (arrow). The anterior part of the LP has been angulated downwards, apparently by the downward vector (white arrow) acting against the cervix (CX)/uterosacral ligament (USL) complex. The backward/downward vectors create a diagonal vector force, which seems to be pulling open the posterior urethral wall. S, sacrum.
1292
© 2014 The Japanese Urological Association
Copyright of International Journal of Urology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
International Journal of Urology (2014) 21, 1291–1294
Letters to the Editor Linguistic validation of the English version of the Core Lower Urinary Tract Symptom Score The Core Lower Urinary Tract Symptom Score is a selfadministered symptom questionnaire to assess 10 relevant lower urinary tract symptoms thoroughly.1 The Core Lower Urinary Tract Symptom Score was originally developed concurrently in both Japanese and English by bilingual Japanese urologists. Although the English translation had been reviewed by native English-speaking translators, it had not been linguistically validated. We therefore examined the appropriateness of the English version. Appropriate translation requires that the translated version is conceptually equivalent to the original questionnaire, and is also linguistically relevant and acceptable in the target country.2,3 The appropriateness of the translation was examined through the following two steps: translation quality assessment and cognitive debriefing. In translation quality assessment, the soundness of the expressions from a clinical perspective was discussed with six native English-speaking urologists. They all approved the scientific compatibility of the questionnaire with the definitions of the corresponding symptoms by the International Continence Society.4 Regarding understandability of the questionnaire by lay people, minor issues were raised. For the cognitive debriefing, Clinical Study Support Inc. (Aichi, Japan), a research agency, independently recruited and interviewed participants after ethical approval was granted by The University of Tokyo. Five native English-speaking Americans residing in Japan were debriefed to ensure that they were able to read and understand the translation properly (two men and three women, mean age 65.2 years, mean questionnaire
Table 1
completion time 1.8 min).2 All of the participants responded that the questionnaire was, overall, easy to understand and answer. However, several issues were raised and discussed, as follows. First, although all the participants understood the meaning of Q3, four participants commented that “postpone”1 is not a common word and suggested an alternative word, such as “control”, “hold”, “prevent” or “stop”. Consequently, “postpone” was replaced with “control” for better understanding. Similarly, although all the participants understood the meaning of Q5, one participant commented that “strain” is not commonly used. Thus, “strain” was changed to “exert yourself ”. Second, two participants commented that in Q9, the location of “bladder” was not easy to imagine; therefore, we added an explanation in parentheses. Finally, one participant pointed out that the question items should be in past tense to emphasize that the questionnaire is asking about the past week. In response, all of the questions were revised to the past tense. Additionally, to make the questions sound more natural, the following wordings were revised: no to never (answer choice); and incomplete emptying of the bladder to emptying the bladder incompletely (Q8). After these revisions, the translation was back-translated into Japanese. The original developers confirmed conceptual equivalence between the translation and the Japanese CLSS (Table 1). In conclusion, the appropriateness of the translated English version of the Core Lower Urinary Tract Symptom Score was confirmed after assessing translation quality and carrying out cognitive debriefing.
Core Lower Urinary Tract Symptom Score Questionnaire
Please circle the number that applies best to your urinary condition during the last week. Q1. How many times did you typically urinate from waking in the morning until sleeping at night?
0 1 2 3 −7 8–9 10–14 15– Q2. How many times did you typically urinate from sleeping at night until waking in the morning? 0 1 2 3 0 1 2–3 4– How often did you have the following symptoms? Never Rarely Sometimes Often Q3. A sudden strong desire to urinate, which is difficult to control 0 1 2 3 Q4. Leaking of urine because you cannot hold it 0 1 2 3 Q5. Leaking of urine, when you cough, sneeze, or exert yourself 0 1 2 3 Q6. Slow urinary stream 0 1 2 3 Q7. Need to strain when urinating 0 1 2 3 Q8. Feeling of emptying the bladder incompletely after urination 0 1 2 3 Q9. Pain in the bladder (lower belly) 0 1 2 3 Q10. Pain in the urethra 0 1 2 3 Q11. Among the symptoms above (questions 1 to 10), please choose up to 3 symptoms that you consider to have had a significant impact on your daily life. 1 2 3 4 5 6 7 8 9 10 Not applicable Q12. Among the symptoms you chose in Q11, please choose one symptom that you consider to have had the most significant impact on your daily life. 1 2 3 4 5 6 7 8 9 10 Not applicable Q13. If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted Pleased Mostly satisfied Mixed, about equally satisfied and dissatisfied Mostly dissatisfied Unhappy Terrible 0 1 2 3 4 5 6
© 2014 The Japanese Urological Association
1291
bs_bs_banner
LETTERS TO THE EDITOR
Acknowledgment
References
We thank Dr Motoki Saito, Department of Pharmacology, School of Medicine, Kochi University, Nankoku, Japan, for introducing native English-speaking urologists to us.
1 Homma Y, Yoshida M, Yamanishi T, Gotoh M. Core Lower Urinary Tract Symptom score (CLSS) questionnaire: a reliable tool in the overall assessment of lower urinary tract symptoms. Int. J. Urol. 2008; 15: 816–20. 2 Wild D, Grove A, Martin M et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes measures: report of the ISPOR task force for translation and cultural adaptation. Value Health 2005; 8: 94–104. [Cited 20 May 2011.] Available from URL: http://www.ispor.org/workpaper/research_practices/PROTranslation _Adaptation.pdf. 3 Dewolf L, Koller M, Velikiva G et al.; on behalf of the EORTC Quality of Life Group. EORTC Quality of Life Group Translation Procedure, 3rd edn. EORTC Quality of Life Group Publication, Brussels, 2009. 4 Abrams P, Cardozo L, Fall M et al. The standardization of terminology of lower urinary tract function: report from the Standardisation Sub-Committee of the International Continence Society. Neurourol. Urodyn. 2002; 21: 167–78.
Yukio Homma M.D., Ph.D. and Tetsuya Fujimura M.D., Ph.D. Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan [email protected] DOI: 10.1111/iju.12584
Conflict of interest YH received research funding and speech honorarium from Astellas Pharma, Kyorin Pharmaceutical, Ono Pharmaceutical, Taiho Pharmaceutical and Pfizer Japan.
Female urethra is actively opened out by an external striated muscle mechanism during micturition, exponentially reducing intraurethral resistance to flow against the uterosacral ligaments to actively open the posterior urethral wall before detrusor contraction, as shown by Watanabe et al.1 X-ray evidence of this external opening mechanism was presented in the second exposition of the theory in 1993,3 and further X-ray and electromyography evidence in 1997.4,5 This external striated muscle mechanism causes the urethra to funnel, exponentially lowering the resistance to flow immediately before the expulsive action of the detrusor, resistance to flow being exponentially determined inversely to the fifth power of the radius.6 To find a clinical imperative for such a mechanism, one need look no further than paraplegics: cord
I am writing to support the findings of Watanabe et al., who showed that the urethra actively opens from the very beginning of micturition.1 This is important work, as the overwhelming concept at the moment is that the pelvic muscles relax before and during micturition. I present our own work in this field. In 1990, the integral theory described three vectors acting around the pubourethral ligament: forward, backwards and downwards to activate urethral closure, shown in Figure 1. The theory predicted that immediately before the commencement of voiding, the forward closure vector (pubococcygeus muscle) relaxed.2 This allowed the posterior vectors (levator plate and the conjoint longitudinal muscle of the anus) to contract
S
(a) B
PUL
U
(b)
B
USL V
Bv
S USL
CX CX
R LP
PUL
R V
LP
Fig. 1 Normal patient. X-rays (a) at rest and (b) during micturition, the same patient in a sitting position. At rest, slow twitch contractions angulate the bladder (B), urethra (U), vagina (V) and rectum (R) around the insertion of the pubourethral ligament (PUL) at the midurethra; 10 mL of radiopaque material has been injected into the levator plate (LP), vagina and rectum. Vertical and horizontal broken lines indicate bony co-ordinates. (b) During micturition, the urethra has moved backwards and actively opened out, suggesting relaxation of the forward vector and an active mechanism, which stretches the posterior urethral wall backwards. The vagina and rectum appear to have been stretched backwards by a backward vector (arrow). The anterior part of the LP has been angulated downwards, apparently by the downward vector (white arrow) acting against the cervix (CX)/uterosacral ligament (USL) complex. The backward/downward vectors create a diagonal vector force, which seems to be pulling open the posterior urethral wall. S, sacrum.
1292
© 2014 The Japanese Urological Association
Copyright of International Journal of Urology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
